Nivolumab with fluoropyrimidine- and platinum-based chemotherapy for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma

1.1 Nivolumab with fluoropyrimidine-based and platinum-based combination chemotherapy is recommended as an option for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma in adults whose tumours express PD‑L1 at a level of 1% or more. It is recommended only if:

1.2 This recommendation is not intended to affect treatment with nivolumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Standard care for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma is fluoropyrimidine-based and platinum-based chemotherapy (chemotherapy). Some people may have pembrolizumab plus chemotherapy if their tumours express PD‑L1 with a combined positive score (CPS) of 10 or more.

Clinical trial evidence shows that for people whose tumours express PD‑L1 at a level of 1% or more, nivolumab plus chemotherapy increases how long they live compared with chemotherapy alone. It also increases the time before their cancer gets worse. Nivolumab plus chemotherapy has only been indirectly compared with pembrolizumab plus chemotherapy. Uncertainty in this comparison means it is difficult to determine which combination is more effective. The cost-effectiveness estimates for nivolumab compared with pembrolizumab are also uncertain, but nivolumab is unlikely to be cost effective compared with pembrolizumab.

When compared with chemotherapy alone, nivolumab plus chemotherapy meets NICE's criteria to be a life-extending treatment at the end of life. Taking this into account, the cost-effectiveness estimates are likely within what NICE considers an acceptable use of NHS resources for this group. Therefore, nivolumab plus chemotherapy is recommended when pembrolizumab plus chemotherapy is unsuitable.

Tests for suitability of nivolumab (tumours express PD‑L1 at 1% or more) or pembrolizumab (tumours express PD‑L1 with CPS of 10 or more) should be done at the same time. This is to minimise any unnecessary delays in accessing treatment.